Trial Outcomes & Findings for Effect of Acetyl-L-carnitine in Migraine (NCT NCT01695317)

NCT ID: NCT01695317

Last Updated: 2022-04-13

Results Overview

The number of days per 4 weeks with moderate or severe headache lasting ≥ 4 hours or if treated with the patient's usual headache medication (usually a triptan) as the primary endpoint.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 72 participants
• Primary outcome timeframe: last 4 weeks
• Results posted on: 2022-04-13

Participant Flow

Participant milestones

Measure	Acetyl-L-carnitine First, Then Sugar Pills Period 1: Acetyl-L-carnitine tablets Week 1: 500 mg x 3 (1.5 g), Week 2-12: 500 mg x 6 (3.0 g) Period 2: Sugar tablets (500 mg dextrose and citric acid): Week 1: 1 tablet x 3 (1,5 g), week 2-12: 6 tablets (3.0 g)	Sugar Pills First, Then Acetyl-L-carnitine Period 1: Sugar tablets (500 mg dextrose and citric acid): Week 1: 1 tablet x 3 (1,5 g), week 2-12: 6 tablets (3.0 g) Period 2: Acetyl-L-carnitine: Week 1: 500 mg x 3 (1.5 g), Week 2-12: 500 mg x 6 (3.0 g)
Period 1 in the Cross-over Design STARTED	36	36
Period 1 in the Cross-over Design COMPLETED	34	35
Period 1 in the Cross-over Design NOT COMPLETED	2	1
Cross-over to Period 2 STARTED	34	35
Cross-over to Period 2 COMPLETED	30	1
Cross-over to Period 2 NOT COMPLETED	4	34

Reasons for withdrawal

Measure	Acetyl-L-carnitine First, Then Sugar Pills Period 1: Acetyl-L-carnitine tablets Week 1: 500 mg x 3 (1.5 g), Week 2-12: 500 mg x 6 (3.0 g) Period 2: Sugar tablets (500 mg dextrose and citric acid): Week 1: 1 tablet x 3 (1,5 g), week 2-12: 6 tablets (3.0 g)	Sugar Pills First, Then Acetyl-L-carnitine Period 1: Sugar tablets (500 mg dextrose and citric acid): Week 1: 1 tablet x 3 (1,5 g), week 2-12: 6 tablets (3.0 g) Period 2: Acetyl-L-carnitine: Week 1: 500 mg x 3 (1.5 g), Week 2-12: 500 mg x 6 (3.0 g)
Period 1 in the Cross-over Design Withdrawal by Subject	2	1
Cross-over to Period 2 Withdrawal by Subject	4	34

Baseline Characteristics

Effect of Acetyl-L-carnitine in Migraine

Baseline characteristics by cohort

Measure	Acetyl-L-carnitine First, Then Sugar Pills n=36 Participants Period 1: Acetyl-L-carnitine tablets Acetyl-L-carnitine: Week 1: 500 mg x 3, Week 2-12: 500 mg x 6 Period 2: Glucose with lemon acid Sugar pills Week 1: 500 mg x 3, Week 2-12: 500 mg x 6	Sugar Pills First, Then Acetyl-L-carnitine n=36 Participants Period 1: Glucose with lemon acid Sugar pills Week 1: 500 mg x 3, Week 2-12: 500 mg x 6 Period 2: Acetyl-L-carnitine tablets Acetyl-L-carnitine: Week 1: 500 mg x 3, Week 2-12: 500 mg x 6	Total n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	39 years STANDARD_DEVIATION 14 • n=5 Participants	39 years STANDARD_DEVIATION 14 • n=7 Participants	39 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment Norway	36 participants n=5 Participants	36 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: last 4 weeks

Population: Headache days per four week

The number of days per 4 weeks with moderate or severe headache lasting ≥ 4 hours or if treated with the patient's usual headache medication (usually a triptan) as the primary endpoint.

Outcome measures

Measure	Acetyl-L-carnitine n=72 Participants Acetyl-L-carnitine tablets Acetyl-L-carnitine: Week 1: 500 mg x 3, Week 2-12: 500 mg x 6	Sugar Pills n=72 Participants Glucose with lemon acid Acetyl-L-carnitine: Week 1: 500 mg x 3, Week 2-12: 500 mg x 6
Headache Days	5.1 Headache days per 4 weeks Standard Deviation 2.8	5.2 Headache days per 4 weeks Standard Deviation 3.3

SECONDARY outcome

Timeframe: Last 4 weeks

Population: Headache hours per 4 weeks

Secondary measures will be: Days with migraine; days with headache; hours with headache; headache intensity (0-3 scale) on days with headache; doses of analgesics; doses of triptans; days with sick leave; number of responders (≥ 50% decrease in migraine days compared with baseline); incidence of side effects recorded openly.

Outcome measures

Measure	Acetyl-L-carnitine n=72 Participants Acetyl-L-carnitine tablets Acetyl-L-carnitine: Week 1: 500 mg x 3, Week 2-12: 500 mg x 6	Sugar Pills n=72 Participants Glucose with lemon acid Acetyl-L-carnitine: Week 1: 500 mg x 3, Week 2-12: 500 mg x 6
Days With Migraine and Side Effects	36.4 Headache hours per 4 weeks Standard Deviation 30.2	37.0 Headache hours per 4 weeks Standard Deviation 38.9

Adverse Events

Acetyl-L-carnitine

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Sugar Pills

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Acetyl-L-carnitine n=72 participants at risk Acetyl-L-carnitine tablets Acetyl-L-carnitine: Week 1: 500 mg x 3, Week 2-12: 500 mg x 6	Sugar Pills n=72 participants at risk Glucose with lemon acid Sugar tablets (500 mg dextrose and citric acid): Week 1: 1 tablet x 3 (1,5 g), week 2-12: 6 tablets (3.0 g):
Gastrointestinal disorders advedrse events	16.7% 12/72 • Number of events 12	26.4% 19/72 • Number of events 19
Nervous system disorders More severe headache	8.3% 6/72 • Number of events 6	4.2% 3/72 • Number of events 3
Nervous system disorders Bad taste	9.7% 7/72 • Number of events 7	2.8% 2/72 • Number of events 2

Additional Information

Dr. knut Hagen

St. olavs Hospital

Phone: 95401579

Email: knut.hagen@stolav.no

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place