Arthemeter-lumefantrine (ART-LUM) is an antimalaria drug manufactured as fixed combination tablets, each containing 20 mg of artemether and 120 mg of lumefantrine. ART-LUM was administrated according to body weight as six consecutive doses: The first dose at diagnosis and the second dose eight hours later, 0- 24-48 hours

Artesunate mefloquine (ASMQ) is an antimalaria drug administered as a combination of artesunate, 4 mg/kg/day, with mefloquine, 8 mg/kg/day orally once a day for 3 days or three times, at an interval of 24 hours (0 h - 24 h - 48 h).

Dihydroartemisinin piperaquine (DHA-PQ ) is an antimalaria drug administered as a combination of dihydroartemisinin, 2.5 mg per kg, with piperaquine phosphate, 20mg per kg daily for 3 days or three times, at an interval of 24 hours

Oral paracetamol is administered at of 50mg/kg body weight per day in three divided doses for fever exceeding 37.5oC.

amoxicillin is an antibiotic administered at 50mg per kg body weight per day for seven days in the event of concomitant bacterial infection, absent on day 0 but present during the follow up.

Quinine is an antimalarial recommended by the WHO and NMCP to be used as second line treatment for malaria. In this study, for cases of treatment failure with the artemisinin based combination therapies, quinine sulphate is administered as a second line or rescue drug at a dose of 25mg base per kg body weight per day in three divided doses for five days. The participant is then classified as ETF or LTF and excluded from the study.

Drug Resistant Malaria Due to Plasmodium Falciparum

Randomization codes were computer-generated by an offsite investigator and provided to a study nurse responsible for treatment allocation. All other study personnel were blinded to the treatment assignments, and patients were not informed of their treatment regimen. Participants from Group 1: AL, Group 2 : DHAP, Group3 : ASMQ were also given appointment card for days 1, 2, 3, 7, 14, 21, 28, 35 and 42 for clinical examination and blood smears. Blood was taken on filter paper on each of these visits.

Arthemeter-lumefantrine

Artequin® is an antimalarial drug presented as infant co-formulation of two separate drugs

Artesunate mefloquine

Malacur®. is an antimalarial drug presentad as co-formulation of two separate drugs

Dihydroartemisinin piperaquine

Paracetamol, is an antipyretic drug, presented as tablets or syrup in infants formulation

Paracetamol

Amoxicillin is an antibiotic with no reported activity on plasmodium

Amoxicillin

quinine sulphate is an antimalaria drug administered as a second line or rescue drug

Quinine

CDC Hospital

Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa

Assessment of Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa

The primary endpoint was the 28-day and 42-day cure rates and was defined as proportion of patients with adequate clinical and parasitological response (ACPR) after 28 and 42 days of follow-up. Absence of parasitemia until day 28 and day 42 irrespective of axillary temperature was categorized as an adequate clinical and parasitologic response (ACPR). Secondary endpoints were early treatment failure (ETF), late clinical failure (LCF), late parasitological failure (LPF), adverse events (clinical and laboratory abnormalities), anaemia (Hematocrit < 30%), clearance rate of fever and parasitaemia, and gametocyte

The ability of the drug to restore hemoglobin level back to normal

The ability of the drug to completely eliminate plasmodium in the blood stream including participant without symptoms of fever

blood sample from patients with parasitaemia at any day of follow-up are analysed by PCR to evaluated the genetic profile of the MSP1 and MSP2

University of Bamenda

Ministry of Science and Technology of the People´s Republic of China

National Institute for Parasitic Disease, Chinese Center for Disease Control and Prevention

Mexiletine, capsule, 150mg, PO BID, 14 days

A total of 23 subjects were enrolled. 11 were randomized to receive study drug first, followed by placebo. 12 subjects received placebo first and study drug second. Overall participant characteristics are displayed in the baseline table.

Total Subjects Enrolled

Age, Customized

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

The average of the daily recording of number of muscle cramps that occurred in the last 24 hours- over a 6 week period.

Mexiletine, capsule, 150mg, PO BID, 14 days
Placebo, capsule, PO BID, 14 days

Mexiletine First/Placebo Second

Placebo, capsule, PO BID, 14 days
Mexiletine, capsule, 150mg, PO BID, 14 days

Placebo First/Mexiletine Second

Daily Muscle Cramps

Daily cramp severity was rated on the 100-unit visual analog scale. Scores ranged from 0 to 100, with 100 being the greatest amount of cramp severity

Mexiletine, capsule, 150mg, PO BID, 14 days
Mexiletine: Sodium channel blocker

Mexiletine First

Placebo, capsule, PO BID, 14 days
Placebo: Placebo

Placebo First

Cramp Severity

First Dose

Washout

Second Dose

Dr. Bjorn Oskarsson

Mexiletine

Placebo

Muscle Cramps in Amyotrophic Lateral Sclerosis

UCD Telehealth Network - Lake Almanor Clinic

UCSD Department of Neurosciences ALS Clinical Trials (ACT) Program

UCLA Neuromuscular Research Program

UCD Telehealth Network

UC Irvine Health ALS & Neuromuscular Center

UC, Davis Medical Center ALS Clinic

Mexiletine for the Treatment of Muscle Cramps in ALS

Bjorn Oskarsson, MD

Assistant Professor of Clinical Neurology

University of California, Davis

ALS Association

Tablets 20 mg/120 of Artemether/Lumefantrine will be given to 124 trial patients

Tablets 25mg/67,5 mg of Artesunate/Amodiaquine will be given to 124 trial patients.

Quinine tablet 125mg + Clindamycin syrup 75mg/5ml will be given to 60 children.

Malaria

Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine. Each dose to be taken with high-fat food or drinks (for example milk).
Weight in kg Number of tablet per dose Age 5 to < 15 kg 1 tablet per dose 15 to < 25 kg 2 tablets per dose 25 to < 35 kg 3 tablets per dose

Artemether/Lumefantrine

Age (Weight in Kg) Dose Treatment duration 2 to 11 months (= 4,5 to < 9kg):1 tablet (25 mg/675mg) for 3 days
1 to 5 years (= 9 kg to < 18 kg)1 tablet(25mg/67,5mg)for 3 days

Artesunate/Amodiaquine

this arm consist to 7 days treatment of 60 patients with quinine tablet 125mg + clindamycin syrup as follow;
Quinine:
9 to < 11 kg: ½ tablets 12 to < 19 kg: 1 tablets per dose 20 to < 27 kg: 1½ tablets per dose 28 to < 35 kg: 2 tablets per dose
Clindamycin syrup:
10 mg/kg twice daily

Quinine + Clindamycin

Centre de Santé Lisungi

Kazo Health centre IV

Impact of Artemisinin-based Combination Therapy and Quinine on Treatment Failure and Resistance in Uncomplicated Malaria

A Randomized Clinical Trial to Measure the Impact of Retreatment With an Artemisinin-based Combination on Malaria Incidence and Its Potential Selection of Resistant Strains

Parasitaemia after day 3 in the absence of fever (axillary temperature <37.5°C)

Proportion of children without (PCR not adjusted) treatment failure (TF28U): all treatment failures detected during the active follow up, regardless of genotyping.

All clinical treatment failures detected during the 42 days follow up for the first line treatment, with and without PCR adjustment. As no active monitoring of parasitaemia after day 3 is planned this includes ETF and LCF following WHO criteria.

The time (in days) from the time of randomization to the first two consecutive measurements on 2 different days of axillary temperature below 37.5°C.

Asexual parasite clearance time is defined as the time (in days) from time of randomization to 2 consecutive negative blood slides (collected at different days). The time to the event will be taken as the time to the first negative slide.
5. Gametocytaemia (prevalence and density) at day 7, 14, 21 and 28 after treatment.

Variation in Hb level between two measurements.

Development of danger signs or severe malaria on Day 0, Day 1 Day 2 or Day 3, in the presence of parasitaemia Parasite density on Day 2 > Day 0 count, irrespective of axillary temperature Presence of parasitaemia on Day 3 with fever (axillary temperature ≥ 37.5°C) Parasitaemia on Day 3 ≥ 25 % of count on Day 0.

Development of danger signs or severe malaria after Day 3 in the presence of parasitaemia Presence of parasitaemia and fever on any day from Day 4 to Day 28

Jean-Pierre Van geertruyden

Prof

Universiteit Antwerpen

European and Developing Countries Clinical Trials Partnership (EDCTP)

Fund for Scientific Research, Flanders, Belgium

Institute of Tropical Medicine, Belgium

University of Kinshasa

Centre Muraz

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Makerere University

Vitamin D arm
vitamin d: After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks.

Vitamin D 50,000 U/d x 10d, + Vitamin D 50,000 U Weekly 7 Wks

placebo
placebo: After a two-week wash-in, subjects will take a placebo capsule once daily for 10 days, followed by a once weekly maintenance dose for 7 weeks.

Placebo x 10d, + Placebo Weekly 7 Wks

Total

Sex: Female, Male

Eligibility requirements included having at least two cramps weekly.

Leg cramp frequency mean over 2 week prestudy

Eligibility requirements included having 25-hydroxyvitamin D concentration between 20 and 45 ng/ml.

25-hydroxyvitamin D concentration

Eligibility requirements included having normal serum calcium ranging from 8.5-10.2 mg/dL.

Serum calcium

Urine calcium /creatinine ratio

Estimated Glomerular Filtration Rate (eGFR)

Difference in number of leg cramps per day during treatment period compared to baseline period.
Participants will undergo a 2-week "diary run-in" period to confirm cramp frequency. After a 2 week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks. Subjects will record by diary the number and severity of leg cramps from the start of the "diary run-in" until 1 week after the last dose of study drug/placebo.

Vitamin D
vitamin d: After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks.

Vitamin D

Placebo
placebo: After a two-week wash-in, subjects will take a placebo capsule once daily for 10 days, followed by a once weekly maintenance dose for 7 weeks.

Change in the Nocturnal Leg Cramp Rate

Serum calcium was measured to detect any possible correlation between high dose of Vitamin D and hypercalcemia. Hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL.

Serum Calcium Level

Overall Study

Dr. Mary Elliott

Leg Cramps, Nocturnal

After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks.

vitamin d

After a two-week wash-in, subjects will take a placebo capsule once daily for 10 days, followed by a once weekly maintenance dose for 7 weeks.

quinine/mual

Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa

Mexiletine for the Treatment of Muscle Cramps in ALS

Impact of Artemisinin-based Combination Therapy and Quinine on Treatment Failure and Resistance in Uncomplicated Malaria

Vitamin D for Painful Nocturnal Leg Cramps

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