Trial Outcomes & Findings for Theramine® in the Prevention of Migraine Headache (NCT NCT01944059)

NCT ID: NCT01944059

Last Updated: 2016-05-05

Results Overview

The primary outcome measure will be the frequency of migraine and all headache days in the Theramine active group versus the Theramine placebo group during the treatment period.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 31 participants
• Primary outcome timeframe: 4-6 months
• Results posted on: 2016-05-05

Participant Flow

Blinding information is not available from Funder, but should it become available results will be updated.

Participant milestones

Measure	All Participants 2 capsules before breakfast and dinner (BID) for 16 weeks. Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine. Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors. Placebo (l-alanine): Theramine like placebo comparator
Overall Study STARTED	31
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	All Participants 2 capsules before breakfast and dinner (BID) for 16 weeks. Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine. Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors. Placebo (l-alanine): Theramine like placebo comparator
Overall Study Lost to Follow-up	1
Overall Study Physician Decision	3
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	2

Baseline Characteristics

Theramine® in the Prevention of Migraine Headache

Baseline characteristics by cohort

Measure	All Participants n=31 Participants 2 capsules before breakfast and dinner (BID) for 16 weeks. Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine. Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors. Placebo (l-alanine): Theramine like placebo comparator
Age, Continuous	44.8 years n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 4-6 months

Population: Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.

The primary outcome measure will be the frequency of migraine and all headache days in the Theramine active group versus the Theramine placebo group during the treatment period.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4-6 months

Population: Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.

The percent change in migraine and headache frequency will be defined as [frequency/baseline phase - frequency/treatment phase] divided by [frequency/baseline phase].

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4-6 months

Population: Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.

Differences in the scores for the HIT-6 disability inventory between baseline and the last study visit will be analyzed.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants n=31 participants at risk 2 capsules before breakfast and dinner (BID) for 16 weeks. Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine. Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors. Placebo (l-alanine): Theramine like placebo comparator
Endocrine disorders Diabetic Ketoacidosis	3.2% 1/31 • Number of events 1 Blinding information is not available from Funder. Data analysis was not completed and adverse event terms for non-serious adverse events are only available by Organ System.
Respiratory, thoracic and mediastinal disorders Asthma Exacerbation	3.2% 1/31 • Number of events 1 Blinding information is not available from Funder. Data analysis was not completed and adverse event terms for non-serious adverse events are only available by Organ System.

Other adverse events

Measure	All Participants n=31 participants at risk 2 capsules before breakfast and dinner (BID) for 16 weeks. Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine. Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors. Placebo (l-alanine): Theramine like placebo comparator
Infections and infestations Infections and Infestations	12.9% 4/31 • Number of events 4 Blinding information is not available from Funder. Data analysis was not completed and adverse event terms for non-serious adverse events are only available by Organ System.
Nervous system disorders Nervous System Disorder	16.1% 5/31 • Number of events 5 Blinding information is not available from Funder. Data analysis was not completed and adverse event terms for non-serious adverse events are only available by Organ System.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	3.2% 1/31 • Number of events 1 Blinding information is not available from Funder. Data analysis was not completed and adverse event terms for non-serious adverse events are only available by Organ System.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	9.7% 3/31 • Number of events 3 Blinding information is not available from Funder. Data analysis was not completed and adverse event terms for non-serious adverse events are only available by Organ System.
Gastrointestinal disorders Gastrointestinal Disorders	29.0% 9/31 • Number of events 9 Blinding information is not available from Funder. Data analysis was not completed and adverse event terms for non-serious adverse events are only available by Organ System.
General disorders General Disorders	3.2% 1/31 • Number of events 1 Blinding information is not available from Funder. Data analysis was not completed and adverse event terms for non-serious adverse events are only available by Organ System.
Skin and subcutaneous tissue disorders Skin and subcutaneious tissue disorders	9.7% 3/31 • Number of events 3 Blinding information is not available from Funder. Data analysis was not completed and adverse event terms for non-serious adverse events are only available by Organ System.
Eye disorders Eye Disoders	6.5% 2/31 • Number of events 2 Blinding information is not available from Funder. Data analysis was not completed and adverse event terms for non-serious adverse events are only available by Organ System.
Psychiatric disorders Psychiatric disorders	3.2% 1/31 • Number of events 1 Blinding information is not available from Funder. Data analysis was not completed and adverse event terms for non-serious adverse events are only available by Organ System.
Metabolism and nutrition disorders Metabolism and nutritional disorders	3.2% 1/31 • Number of events 1 Blinding information is not available from Funder. Data analysis was not completed and adverse event terms for non-serious adverse events are only available by Organ System.
Reproductive system and breast disorders Reproductive system and breast disoders	3.2% 1/31 • Number of events 1 Blinding information is not available from Funder. Data analysis was not completed and adverse event terms for non-serious adverse events are only available by Organ System.
Surgical and medical procedures Surigical and Medical Procedures	3.2% 1/31 • Number of events 1 Blinding information is not available from Funder. Data analysis was not completed and adverse event terms for non-serious adverse events are only available by Organ System.

Additional Information

Vincent Martin, MD

University Cincinnati Physicians Company

Phone: 513-558-7581

Email: vincent.martin@uc.edu

Results disclosure agreements

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