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Theramine® in the Prevention of Migraine Headache

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ClinicalTrials.gov Identifier: NCT01944059
Recruitment Status : Terminated (Funding Discontinued)
First Posted : September 17, 2013
Results First Posted : May 4, 2016
Last Update Posted : May 5, 2016
Sponsor:
Collaborator:
Targeted Medical Pharma
Information provided by (Responsible Party):
Vincent Martin, MD, Targeted Medical Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Migraine Headaches
Interventions Drug: Theramine (medical food/old drug)
Other: Placebo (l-alanine)
Enrollment 31
Recruitment Details  
Pre-assignment Details Blinding information is not available from Funder, but should it become available results will be updated.
Arm/Group Title All Participants
Hide Arm/Group Description

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

Period Title: Overall Study
Started 31
Completed 24
Not Completed 7
Reason Not Completed
Lost to Follow-up             1
Physician Decision             3
Withdrawal by Subject             1
Adverse Event             2
Arm/Group Title All Participants
Hide Arm/Group Description

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 Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants
44.8
(22 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
26
  83.9%
Male
5
  16.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Hispanic or Latino
1
   3.2%
Not Hispanic or Latino
30
  96.8%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
11
  35.5%
White
18
  58.1%
More than one race
2
   6.5%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
1.Primary Outcome
Title Number of Migraine/Headache Days
Time Frame 4-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.
Arm/Group Title Theramine Placebo (L-alanine)
Hide Arm/Group Description:

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.

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.

Placebo (l-alanine): Theramine like placebo comparator

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Percent Change in Migraine and Headache Frequency
Hide Description The percent change in migraine and headache frequency will be defined as [frequency/baseline phase - frequency/treatment phase] divided by [frequency/baseline phase].
Time Frame 4-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.
Arm/Group Title Theramine Placebo (L-alanine)
Hide Arm/Group Description:

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.

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.

Placebo (l-alanine): Theramine like placebo comparator

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title HIT-6
Hide Description Differences in the scores for the HIT-6 disability inventory between baseline and the last study visit will be analyzed.
Time Frame 4-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.
Arm/Group Title Theramine Placebo (L-alanine)
Hide Arm/Group Description:

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.

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.

Placebo (l-alanine): Theramine like placebo comparator

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title All Participants
Hide Arm/Group Description

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

All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%) # Events
Total   1/31 (3.23%)    
Endocrine disorders   
Diabetic Ketoacidosis * 1 [1]  1/31 (3.23%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma Exacerbation * 1 [1]  1/31 (3.23%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
Not related to study treatment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%) # Events
Total   23/31 (74.19%)    
Eye disorders   
Eye Disoders * 1  2/31 (6.45%)  2
Gastrointestinal disorders   
Gastrointestinal Disorders * 1  9/31 (29.03%)  9
General disorders   
General Disorders * 1  1/31 (3.23%)  1
Infections and infestations   
Infections and Infestations * 1  4/31 (12.90%)  4
Metabolism and nutrition disorders   
Metabolism and nutritional disorders * 1  1/31 (3.23%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal and connective tissue disorders * 1  3/31 (9.68%)  3
Nervous system disorders   
Nervous System Disorder * 1  5/31 (16.13%)  5
Psychiatric disorders   
Psychiatric disorders * 1  1/31 (3.23%)  1
Reproductive system and breast disorders   
Reproductive system and breast disoders * 1  1/31 (3.23%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory, thoracic and mediastinal disorders * 1  1/31 (3.23%)  1
Skin and subcutaneous tissue disorders   
Skin and subcutaneious tissue disorders * 1  3/31 (9.68%)  3
Surgical and medical procedures   
Surigical and Medical Procedures * 1 [1]  1/31 (3.23%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
Elective surgery
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Vincent Martin, MD
Organization: University Cincinnati Physicians Company
Phone: 513-558-7581
Responsible Party: Vincent Martin, MD, Targeted Medical Pharma
ClinicalTrials.gov Identifier: NCT01944059     History of Changes
Other Study ID Numbers: VM-2013-001
First Submitted: September 12, 2013
First Posted: September 17, 2013
Results First Submitted: May 3, 2016
Results First Posted: May 4, 2016
Last Update Posted: May 5, 2016